Pulmonx Corporation: FDA clearances and approvals
Pulmonx Corporation has 9 FDA 510(k) clearances (first 1998, latest 2026), plus 1 PMA decision, across 5 product codes in 2 review panels. Median 510(k) review time: 143 days. Since 2017 its median was 132 days, against 135 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Pulmonx Corporation. It is the industry lead sponsor of 13 device clinical trials on ClinicalTrials.gov. It files with the SEC as Pulmonx Corp (LUNG).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 192 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 24 |
| 2022 | 1 | 120 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 143 |
Review time against the same product codes
Since 2017, Pulmonx Corporation's cleared 510(k)s took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 135 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 4 | 4 |
| BZG | Spirometer, Diagnostic | 3 | 3 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| NJK | Valve, Pulmonary | 1 | 0 |
Review panels
- Anesthesiology (9)
- Radiology (1)
Most recent Pulmonx Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253096 | Chartis Precision Catheter | CBI | 2026-02-13 | 143 |
| K222340 | Chartis Precision Catheter | CBI | 2022-12-01 | 120 |
| K212494 | Lung Image Analysis | JAK | 2021-09-02 | 24 |
| K180011 | Pulmonx Chartis Tablet Console | BZG | 2018-07-13 | 192 |
| K111764 | CHARTIS CONSOLE | BZG | 2011-11-10 | 140 |
| K111522 | CHARTIS CATHETER MODEL CHR-CA-12.0 | CBI | 2011-09-29 | 119 |
| K083883 | CHARTIS CATHETER | CBI | 2009-06-25 | 178 |
| K083199 | CHARTIS CONSOLE | BZG | 2009-06-25 | 238 |
| K973191 | THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM | BTR | 1998-02-13 | 172 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180002 | PMA | Zephyr Endobronchial Valve System | 2018-06-29 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2023-08-31.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Pulmonx Corporation is the industry lead sponsor of 13 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06332885: Zephyr Valve Japan Post-Marketing Surveillance (Recruiting, started 2024-03-12)
- NCT06035120: An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema (Recruiting, started 2024-02-22)
- NCT04517916: Zephyr Etude Post-Inscription (French Registry) (Completed, started 2021-01-04)
- NCT04559464: Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status (CONVERT) (Completed, started 2020-12-15)
- NCT04465461: Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion (Completed, started 2020-06-04)
SEC filings
Pulmonx Corp (LUNG): EDGAR filings, CIK 1127537. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Pulmonx Corporation have?
Pulmonx Corporation has 9 FDA 510(k) clearances (first 1998, latest 2026), plus 1 PMA decision, across 5 product codes in 2 review panels.
How long does FDA take to clear Pulmonx Corporation's 510(k)s?
The median time from FDA receipt to decision across Pulmonx Corporation's cleared 510(k)s is 143 days. Since 2017: 132 days, versus 135 days for all cleared 510(k)s in the same product codes.
What devices does Pulmonx Corporation make?
Its most frequent FDA product codes are CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector), 4); BZG (Spirometer, Diagnostic, 3); BTR (Tube, Tracheal (W/Wo Connector), 1).
Has Pulmonx Corporation had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Pulmonx Corporation; the most recent began 2023-08-31. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 9 Pulmonx Corporation clearances with predicates and recalls
- Run predicate analysis for product code CBI, Pulmonx Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.